In a bone marrow transplant (BMT), healthy blood stem cells and white blood cells are infused into a patient’s body to replace damaged or diseased bone marrow and in many cases, to clear out the remainder of cancer cells in the patient’s system. BMTs may use cells from the patient’s own body (autologous transplant) or from a donor (allogeneic transplant).
An exaggerated immune response occurs when the donated white blood cells register the host body's tissues and organs as foreign antigens and attack them. This primary complication is termed Graft vs Host Disease, or GvHD. Upon the occurrence of GvHD, patients are typically treated with standard-of-care corticosteroids, antibodies, or small-molecules. Such treatment regimens are known in the scientific and medical communities to have poor efficacy profiles, as well as potentially compromising patients’ ability to respond to immunological challenges, or exposing patients to severe side effects, such as high blood pressure and eye disorders.

Allocetra™ is being developed to prevent life-threatening post-transplantation complications, without exposing patients to the risk of infection.

Some patients, who develop severe GvHD post-BMT, do not respond to corticosteroids, and have a dire mortality rate of up to 90% within the first 12 months post-BMT. Severe GvHD involves a cytokine storm that may lead to multiple organ failure and potential death.

Allocetra™ is being developed to effectively treat steroid-refractory GvHD patients for whom survival forecast is bleak.

While 55% of Americans have never heard of sepsis, it is the #3 cause of mortality in the United States. It is categorized as the body’s overwhelming, life-threatening response to an infection or inflammation. It can potentially lead to tissue damage, organ failure, and death. In many sepsis cases, at the same time that the medical team is administering the best standard of care, mainly antibiotics and fluids, a cytokine storm occurs. Such hyper-immune activity may result in an attack of immune killer cells (e.g., T-cells, B-cells, natural killer cells) on healthy organs of the patient, such as the heart, brain, lungs, liver, kidneys, and others. This attack may lead to organ damage, multiple organ failure, and death.

Allocetra™ is being developed for the prevention of organ failure and mortality in patients with sepsis, offering a novel immunotherapeutic treatment approach to solve one of healthcare’s most acute challenges.

While first-generation immuno-oncology therapies for non-solid tumors, such as checkpoint inhibitors and CAR-T procedures, present a remarkable therapeutic advance, solid tumors are harder to treat, primarily due to the complex and interconnected tumor microenvironment (TME). Enlivex had discovered a proprietary “immune checkpoint” pathway for solid tumors, which is activated by the engulfment of Allocetra™.

Allocetra™ is being developed as an adjunctive “immune checkpoint” therapy in combination with CAR-T, TCRs, and other any solid cancer agents.